ARITAVI 60 mg. 28 capsules

What is Aritavi and what it is used
Aritavi contains the active substance duloxetine. Aritavi increases the levels of serotonin and norepinephrine in the nervous system.

Aritavi is used in adults to treat:
depression;
generalized anxiety disorder (constant feeling of anxiety or nervousness);
diabetic neuropathic pain (often described as burning, stabbing, stinging, shooting or pain like an electric shock. There may be a loss of sensation in the affected area, or sensations such as touch, heat, cold or pressure may cause pain).
For most people with depression or anxiety Aritavi starts to work within two weeks of starting treatment, but it may take 2-4 weeks before you feel better. Tell your doctor if you feel better after travel time. When you feel better, your doctor may continue to give you appoint Aritavi to prevent the resumption of your depression or anxiety.
In patients with diabetic neuropathic pain treatment may take several weeks before you feel better. Tell your doctor if you feel better after two months.

2. What you need to know before taking Aritavi
Do not take Aritavi if:
you are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6);
have liver disease;
have severe kidney disease;
taking or the last 14 days you are taking other medicines known as monoamine oxidase inhibitor (MAOI) (see "Other medicines and Aritavi");
taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat certain infections;
taking other medicines containing duloxetine (see 'Other medicines and Aritavi ").
Talk to your doctor if you have high blood pressure or heart disease. Your doctor will tell you whether you should take Aritavi.

Warnings and Precautions
Aritavi may not be suitable for you because of the following reasons. Consult your doctor before taking Aritavi if:
taking other medicines to treat depression (see 'Other medicines and Aritavi ");
taking herbal treatment with St. John's wort (Hypericum perforatum);
have kidney disease;
You have had seizures (fits);
you had an obsession;
suffer from bipolar disorder;
have eye problems such as certain kinds of glaucoma (increased eye pressure);
you have a history disorders related to bleeding (tendency to bruise);
You are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly);
currently being treated with another medicine that can cause liver damage;
taking other medicines containing duloxetine (see 'Other medicines and Aritavi ").
Aritavi can cause anxiety or inability to sit or stand in one place. You should tell your doctor if this happens to you.

Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and / or have anxiety disorders can sometimes have thoughts of harming or killing themselves. These may be increased when first starting antidepressants, since the achievement of these medicines all take time, usually about two weeks but sometimes longer.
More likely to think like this if:
you have previously had thoughts of suicide or self-harm;
you are a young person. Data from clinical trials indicate an increased risk behavior related to suicide in young people (under 25 years) with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go immediately to the hospital.
It may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse or are worried about changes in your behavior.

Children or adolescents under 18 years of age
Aritavi usually should not be used for children and adolescents under 18 years of age. Also, you should know that patients under 18 years when used drugs of this class, the risk of side effects such attempts and suicidal thoughts and hostility (predominantly aggression, oppositional behavior and anger) is increased. However, your doctor may prescribe Aritavi patients under 18 because he / she decides that this is in their interest. If your doctor has prescribed Aritavi a patient under 18 and if you wish to discuss this, please go back to it. You should inform your doctor if any of the symptoms listed above appear or worsen when patients under 18 are taking Aritavi. In addition, long-term effects of Aritavi safety on growth, maturation, cognitive and behavioral development have not yet been established for this age group.

Other medicines and Aritavi
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines, including medicines obtained without a prescription.

The main ingredient of Aritavi - duloxetine, is used in other medicines for other conditions:
diabetic neuropathic pain, depression, anxiety and urinary incontinence.

Using more than one of these drugs, at the same time, should be avoided. Check with your doctor if you are already taking other medicines containing duloxetine.

Your doctor will decide whether you can take Aritavi with other drugs. Do not start or stop taking any medicines, including medicines obtained without a prescription or herbal medicines without talking to your doctor.

You should also tell your doctor if you are taking any of the following medications:
Monoamine oxidase inhibitors (MAOIs): You should not take Aritavi if you are taking or have recently (last 14 days) are taking another medicine for depression called a monoamine oxidase inhibitor (MAOI). For example, MAO inhibitors are moclobemide (antidepressant) and linezolid (an antibiotic). The adoption of MAO-inhibitors together with many prescription medicines, including Aritavi can cause serious or even life-threatening side effects. You must wait at least 14 days after you stop taking MAO-inhibitors before you can take Aritavi. It is also necessary to wait at least 5 days after you stop taking Aritavi before taking an MAO inhibitor;
Medicines that cause sleepiness: These are drugs that are prescribed by your doctor, such as benzodiazepines, strong painkillers, antipsychotics, phenobarbital and antihistamines;
Drugs that increase the level of serotonin: Triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), SNRIs (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, St John's Wort and MAO inhibitors (such as moclobemide and linezolid ). These drugs increase the risk of side effects: if you experience any unusual symptoms while taking these medicines with Aritavi, you should consult with your doctor;
Oral anticoagulants or antiplatelet agents: Medicines which thin the blood or prevent the blood to clot. These drugs may increase the risk of bleeding.
Aritavi with food, drinks and alcohol
Aritavi can be taken with or without food. Caution should be exercised if you drink alcohol while being treated with Aritavi.

Pregnancy and lactation
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
Tell your doctor if you are pregnant or if you are trying to become pregnant while taking Aritavi. Use Aritavi only after discussing with your doctor the potential benefits and possible risks to your unborn child;
Make sure your midwife and / or doctor knows you are taking Aritavi. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), resulting in the baby breathe faster and looks livid. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby, you should immediately contact your midwife and / or doctor;
If you take Aritavi at the end of your pregnancy, your baby might have some symptoms when it is born. They usually begin at birth or within a few days after the birth of your baby. These symptoms may include: floppy muscles, shaking, nervousness, poor nutrition, difficulty breathing and seizures. If your baby has any of these symptoms when it is born, or worry about his health, contact your doctor or midwife who will advise;
Tell your doctor if you are breast-feeding. Aritavi use during lactation is not recommended. You should ask your doctor or pharmacist.
Driving and using machines
Aritavi may make you feel sleepy or dizzy. Do not use any tools or machinery until you know how you affect Aritavi.

Aritavi contains sucrose
Aritavi contains sucrose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Aritavi
Always take this medicine exactly as you have been told your doctor or pharmacist. If you're not sure, ask your doctor or pharmacist.
Aritavi is intended for oral administration. You should swallow the capsule whole with a glass of water.

Depression and diabetic neuropathic pain:
Aritavi usual dose of 60 mg once a day, but your doctor will prescribe the dose that is right for you.

In generalized anxiety disorder:
The usual starting dose of Aritavi is 30 mg once daily, after which most patients will receive 60 mg once a day, but your doctor will prescribe the dose that is right for you. The dose may be adjusted up to 120 mg per day depending on how you respond to treatment with Aritavi.

To help you remember to take Aritavi is easier to take it at the same time each day.
Talk to your doctor about how long you should take Aritavi. Do not stop taking Aritavi or change the dose without you have consulted with your doctor. Proper treat your disorder is of great importance to feel better. If not treated, your condition may not go away and may become more serious and more difficult to treat.

If you take more than the amount Aritavi
Contact your doctor or pharmacist immediately if you take more than the amount Aritavi than prescribed by your doctor. Symptoms of overdose include: drowsiness, coma, serotonin syndrome (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating, or muscle stiffness), seizures, vomiting and rapid heart rhythm.

If you forget to use Aritavi
If you miss a dose, take it as soon as you remember. If it's time for your next dose, skip the missed dose and take only a single dose as usual. Do not take a double dose to make up the missed dose. Do not take more than the daily amount Aritavi your prescribed for one day.

If you stop using Aritavi
DO NOT stop taking your capsules without the advice of your doctor even if you feel better.
If your doctor believes that you no longer need Aritavi, he / she will ask you to reduce your dose over at least 2 weeks before stopping treatment.

Some patients who stop taking Aritavi suddenly have had symptoms such as:
dizziness, tingling, like pins and needles or sensation like an electrical current passes (especially in the head), sleep disturbances (vivid dreams, nightmares, insomnia), fatigue, sleepiness, feeling restless or agitated, feeling anxious nausea or vomiting, shaking (tremor), headache, muscle pain, feeling irritable, diarrhea, excessive sweating or dizziness.
These symptoms are usually not serious and disappear within a few days, but if you have symptoms that worry you, talk to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. These reactions are usually mild to moderate in severity and resolved within a few weeks.

Very common side effects (may affect more than 1 in 10 patients):
headache, sleepiness;
feeling sick (nausea), dry mouth.
Common side effects (may affect up to 1 in 10 patients):
lack of appetite;
trouble sleeping, feeling agitated, less sex drive, anxiety, difficulty or failure to experience orgasm, unusual dreams;
dizziness, feeling of weakness, tremors, numbness, including numbness, pricking or tingling of the skin;
blurred vision;
tinnitus (hearing sound in the ears when no external sound);
feeling the heart pumping in the chest;
increased blood pressure, flushing;
more frequent yawning;
constipation, diarrhea, stomach pain, nausea (vomiting), heartburn or indigestion, flatulence;
increased sweating, (itchy) rash;
muscle pain, muscle spasm;
painful urination, frequent urination;
problems getting an erection, changes in ejaculation;
falls (mainly in the elderly), fatigue;
weight loss.
Children and adolescents with depression aged under 18 who were treated with this medicine have some weight loss when you first start taking this medicine. After 6 months of treatment, the weight was increased to what is usual with other children and adolescents age and sex.

Uncommon side effects (may affect up to 1 in 100 patients):
sore throat, causing hoarseness;
suicidal thoughts, sleep problems, teeth grinding or clenching of teeth, feeling disorientated, lack of motivation;
sudden involuntary jerks or twitches of the muscles, sensation of restlessness or inability to sit or stand still, feeling nervous, difficulty concentrating, changes in sense of taste, difficulty controlling movement, for example. lack of coordination or involuntary movements of the muscles, restless legs syndrome, poor quality sleep;
dilated pupils (the dark center of the eye), vision problems;
feeling drowsy or "spinning" (vertigo), ear pain;
rapid and / or irregular heartbeat;
fainting, dizziness, lightheadedness or fainting on standing up, cold fingers and / or feet;
tightness in the throat, nose bleeds;
vomiting blood, or black tarry stools (faeces), gastroenteritis, burping, difficulty swallowing;
inflammation of the liver that may cause abdominal pain and yellowing of the skin or of the whites of the eyes;
night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to bruise;
muscle tension, muscle twitching;
difficulty in passing urine or absence of urination, difficulty to start urination, a need to urinate in the night, the need to urinate more frequently than usual, decreased urine flow;
abnormal vaginal bleeding, abnormal periods, including heavy, painful, irregular or prolonged periods, unusually weak or absent menstrual cycles, pain in the testicles or scrotum;
chest pain, feeling cold, thirst, shivering, feeling hot, abnormal gait;
weight gain;
Aritavi can cause effects that you may not feel as increases in liver enzymes or blood levels of potassium in the blood creatine phosphokinase, sugar or cholesterol.
Rare side effects (may affect up to 1 in 1000 patients):
severe allergic reaction which causes difficulty in breathing or dizziness with swollen tongue or lips, allergic reactions;
underactive thyroid gland, which may cause fatigue or weight gain;
dehydration, low sodium levels in the blood (mainly in the elderly, symptoms may include: a feeling of dizziness, weakness, confusion, sleepiness or fatigue, or nausea or vomiting; more serious symptoms are fainting